TABLE ES-1 Current Status of Foods, Drugs, and Dietary Supplements under Food and Drug Administration (FDA) Regulation

Status

Dietary Supplements

Foodsa

Food Additives

New Drugsb

Premarket approval required

Noc

Nod

Yes

Yes

Risk-benefit analysis conducted by FDA prior to marketing

No

No

No

Yes

Postmarket reporting or surveillance by industry required

No

No

Rarely

Yes

Burden of proof for demonstrating safety or lack thereof

FDA

FDA

Manufacturer

Manufacturer

a Foods (including conventional foods and dietary supplements), unlike drugs, are considered to be safe (reasonable certainty of no harm), and thus risk-benefit analysis is not applicable.

b This description applies to “new” drugs. Many over-the-counter drugs that are not “new drugs” are regulated under FDA’s Over-The-Counter Drug Review procedures, which do not provide for postmarketing surveillance.

c A 75-day premarket notification, but not premarket approval, is required for dietary supplements containing ingredients not marketed before 1994.

d In 2001 FDA proposed a rule requiring marketers of food developed through biotechnology to notify the agency at least 120 days before commercial distribution and to provide information to demonstrate that the product is as safe as its conventional counterpart (FDA, 2001).

evaluation of information in the development of the prototype monographs. Based on a review of comments received and experience gained from completion of the prototype monographs, the proposed framework will be modified as appropriate. The revised framework will be released in a final report of the committee. This final report will also include the six prototype monograph reviews as examples of how the framework as revised can be implemented.

BACKGROUND

Current regulatory approaches to safety evaluation of dietary supplements in the United States are a product of several key pieces of legislation that span from the beginning to the end of the 20th century, culminating in the passage of DSHEA in 1994. The major controversy in considering the safety of dietary supplements has been whether supplements should be regulated as if they were conventional foods, food additives, or as drugs; foods are considered to be safe unless demonstrated otherwise, thus the government bears the burden to prove conventional foods are unsafe (see Table ES-1).

Since 1938 the drug industry has borne the burden of proof in establishing the safety of new drugs before they can be marketed, while the burden of establishing a food as unsafe has continued to remain with FDA. The 1938 Federal Food, Drug, and Cosmetic Act, which established the different burdens of proof, did not address when vitamins, minerals, and botanical products should be regulated as drugs as opposed to foods.

In 1958 the Food Additives Amendment defined food additives and provided that they must undergo a premarket approval process unless they were considered as generally recognized as safe (GRAS). FDA attempted to regulate the botanical industry by alleging that individual



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